A Study to Learn About the Safety of BESPONSA Injection in Pediatric Patients With Acute Lymphocytic Leukemia.

StatusActive, Not Recruiting
PhaseNot specified
SponsorPfizer
Started

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Record History

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  1. Primary endpoints: details revised at 1 of 2 entries
    • Enrollment increased: 10 → 12 participants
    • Eligibility criteria expanded, about 4 words
  2. Enrollment target: 7 to 10v12
  3. Enrollment target: 6 to 7v11
  4. Enrollment target: 4 to 6v10
  5. Enrollment target: 3 to 4v9
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  1. Enrollment target: 1 to 3v8
  2. 4 versions Re-verified since Jan 16, 2025, no change to tracked fieldsv4-v7
  3. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 31, 2024 to Nov 7, 2024
    v3
  4. Enrollment target: 29 to 1
    • Start date: Jul 23, 2024 to Dec 31, 2024
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to learn about the safety of BESPONSA for pediatric patients. . BESPONSA is approved for treatment of relapsed or refractory CD22-positive acute lymphocytic leukemia for pediatric patients. A type of leukemia (blood cancer) that comes on quickly and is fast growing. In acute lymphocytic leukemia, there are too many lymphoblasts (early-stage white blood cells) in the blood and bone marrow. Also called ALL. The registration criteria for this study are: * Never used BESPONSA before * \<18 years at the start of treatment with BESPONSA All patients in this study will receive BESPONSA according to the prescriptions. Patients will be followed up as follow * Treatment phase: From the day of treatment initiation (Day 1) to Day 28 post-treatment to collect information on safety (e.g., adverse events). * Follow-up phase: From Day 29 post-treatment to Week 52 to collect information on VOD/SOS.
Trial Details
NCT Number NCT06476665
Lead Sponsor Pfizer
Conditions
(from sponsor)		 Acute Lymphocytic Leukemia
Related terms Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov